Lead Operator Small Molecule - Lilly Medicine Foundry

Role Summary

The Lilly Medicine Foundry Manufacturing Lead Operator actively supports start-up activities to bring manufacturing equipment into service. The Lead Operator becomes an expert in their assigned area and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. Upon completion of the project phase, the Lead Operator provides on-the-floor, tactical leadership for production of API molecules, ensuring a safety-first, quality-always approach while managing a production process with diverse unit operations and manufacturing skills.

Responsibilities

• Responsible to help enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events.
• Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
• Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift.
• Ensure completion of daily monitoring, testing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
• Serve as a cultural leader for site safety culture, promoting compliant operations and positive safety behaviors. Lead by example and promote accountability at all levels.
• Provide technical leadership for troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
• Follow all applicable procedures for safety event reporting and documentation. This includes following appropriate spill response procedures, escalation of issues, and initiating Emergency Response procedures as needed.
• Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Partner with area management and supervision to understand Foundry strategy and future production needs. Represent and support this strategy in conversations with shift members.
• Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Using specified company-supplied personal protective equipment (PPE) as required.

Qualifications

• HS Diploma/GED
• 3+ years of directly applicable manufacturing experience, GMP and/or chemical processing strongly preferred
• Must be legally authorized to work in the United States. No visa sponsorship anticipated.

Skills

• Previous experience in facility or area start-up environments
• Experience in pharmaceutical or chemical manufacturing operations involving PSM-regulated or hazardous chemicals
• Understanding of FDA guidelines and cGMP requirements
• Strong organizational skills with the ability to handle and prioritize multiple requests
• Knowledge of lean manufacturing principles
• Ability to troubleshoot and triage challenges effectively
• Ability to understand technical nomenclature and language, and work with mathematical formulas
• Effective communication (electronic, written, and verbal)
• Basic computer skills

Education

• Not specified beyond HS Diploma/GED requirement

Additional Requirements

• Position Location: US: Lebanon IN; Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 5%
• Must be able to work a 12-hour rotating shift
• May be required to provide support outside of normal working hours including nights, weekends, and holidays